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The Future of In Vitro Diagnostics

Noninvasive prenatal testing (NIPT). Next-generation sequencing (NGS). Liquid biopsy and circulating tumor cell (CTC) tests. These areas of the in vitro diagnostics (IVD) market are expected to explode in growth during the next few years, wrote Kimberly Scott in the February issue of Clinical Laboratory News.

Statistics from Kalorama Information, publisher of the Worldwide Market for In Vitro Diagnostic Tests, underscore this trend. Over the next 5 years, Kalorama projects that test sales using NGS will soar from $250 million to $800 million, with the number of CTC tests rising from 100 million to 300 million.

Another analysis expects that NIPT will see an annualized growth rate of 20% in the United States and even higher growth rates abroad. Despite these achievements, however, the total market for diagnostics worldwide is slowing down.

Globally, the IVD market is currently worth more than $60 billion, Bruce Carlson, publisher of the Kalorama report, told CLN. Compared with the previous decade, when it grew at a pace of 5% to 6% annually, the market is now only expected to grow by about 4% each year. By 2021, it’s estimated worth will exceed $73 billion.

“Kalorama attributes this slowdown in part to an essentially flat IVD market in Europe and to Medicare’s price cutting in the United States. These factors are partially offset by strong sales growth in China and India, as well as other emerging markets, such as Brazil, Turkey, Korea, Saudi Arabia, and Mexico,” Scott wrote. Carlson named a few other factors, such as the decline in pap smears conducted in the U.S. and Europe, for the slowdown in sales.

Molecular diagnostics is a fast-growing area in this market, with some of the larger IVD companies enjoying success in this area. However, “[it] has not achieved the lofty 20% growth rate once projected by industry observers,” observed Scott. The expansion of lab-developed tests (LDTs), which has hindered commercialization of reagents and test kits, might partly explain why growth has fallen short of expectations, Carlson said.

AACC and other groups are concerned that recent Food and Drug Administration (FDA) draft guidance could threaten growth of NGS tests. The guidance “provides recommendations for designing, developing, and validating NGS-based tests for germline diseases and discusses the use of FDA-recognized standards for regulatory oversight of these tests,” wrote Scott.

AACC’s position is this type of guidance already exists, and that academic medical centers would, from a cost perspective, struggle to meet FDA’s proposed requirements.